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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K073320
Device Name CIMPLICITY SPINAL SYSTEM
Applicant
Spine Smith Partners L.P.
5300 N. Lamar Blvd. #107
Austin,  TX  78751
Applicant Contact ROBERT JONES
Correspondent
Spine Smith Partners L.P.
5300 N. Lamar Blvd. #107
Austin,  TX  78751
Correspondent Contact ROBERT JONES
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/26/2007
Decision Date 02/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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